• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.428-442
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• 2023

In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

• The Journal of the Acoustical Society of Korea
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• v.38 no.4
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• pp.450-458
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• 2019

Passive cavitation imaging method is used to observe the ultrasonic waves generated when a group of bubbles collapses. A problem with passive cavitation imaging is a low resolution and large side lobe levels. Since ultrasound signals generated by passive cavitation take the form of a pulse, the amplitude distribution of signals received across the receive channels varies depending on the direction of incidence. Both the centroid and flatness were calculated to determine weights at imaging points in order to discriminate between the main and side lobe signals from the signal amplitude distribution of the received channel data and to reduce the side lobe levels. The centroid quantifies how the channel data are distributed across the receive channel, and the flatness measures the variance of the channel data. We applied the centroid weight and the flatness to the passive cavitation image constructed using the delay-and-sum focusing and minimum variance beamforming methods to improve the image quality. Using computer simulation and experiment, we show that the application of weighting in delay-and-sum and minimum variance beamforming reduces side lobe levels.

• Journal of Biomedical Engineering Research
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• v.45 no.3
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• pp.128-137
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• 2024

It is necessary to develop a pulsatile Extracorporeal Membrane Oxygenator (p-ECMO) with counter-pulsation control(CPC), which ejects blood during the diastolic phase of the heart rather than the systolic phase, due to the known issues with conventional ECMO causing fatal complications such as ventricular dilation and pulmonary edema. A promising method to simultaneously detect the pulsations of the heart and p-ECMO is to analyze blood pressure waveforms using deep neural network technology(DNN). However, the accurate detection of cardiac rhythms by DNNs is challenging due to various noises such as pulsations from p-ECMO, reflected waves in the vessels, and other dynamic noises. This study aims to evaluate the accuracy of DNNs developed for CPC in p-ECMO, using human-like blood pressure waveforms reproduced in an in-vitro experiment. Especially, an experimental setup that reproduces reflected waves commonly observed in actual patients was developed, and the impact of these waves on DNN judgments was assessed using a multiple DNN (m-DNN) that provides accurate determinations along with a separate index for heartbeat recognition ability. In the experimental setup inducing reflected waves, it was observed that the shape of the blood pressure waveform became increasingly complex, which coincided with an increase in harmonic components, as evident from the Fast Fourier Transform results of the blood pressure wave. It was observed that the recognition score (RS) of DNNs decreased in blood pressure waveforms with significant harmonic components, separate from the frequency components caused by the heart and p-ECMO. This study demonstrated that each DNN trained on blood pressure waveforms without reflected waves showed low RS when faced with waveforms containing reflected waves. However, the accuracy of the final results from the m-DNN remained high even in the presence of reflected waves.